Data / Medical devices / United States / ICU Medical, Inc.
ICU Medical, Inc.: FDA-registered device maker in Southington, CT, United States, 16 510(k) clearances
ICU Medical, Inc. is registered with the FDA (registration 1219611) in Southington, CT, United States. It lists 6 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1219611
- Address
- 201 W Queen St, Southington, CT, United States, 06489
- Owner or operator
- ICU Medical, Inc. (8020727)
- Roles
- Manufacturer
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- Acuvance, Acuvance Jelco Safety IV Catheter, Bivona, Bivona Adjustable Hyperflex, Bivona Disconnect Wedge, Bivona Hyperflex, Bivona® Aire-Cuf® Tracheostomy Tubes, Bivona® Cuff Maintenance Device (CMD¿)open and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Tube Tracheostomy And Tube Cuff | JOH | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 26, 2021 | K211634 | Hypodermic Needle-Pro EDGE Safety Device | FMI | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| June 30, 2016 | K160235 | ViaValve Safety I.V. Catheter | FOZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| March 14, 2012 | K113700 | VIAVALVE SAFETY IV CATHETER | FOZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| February 23, 2009 | K083641 | BIVONA TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| September 12, 2008 | K081440 | BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| August 2, 2007 | K071785 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE | FMI | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| August 1, 2001 | K012128 | PROTECTIV ACUVANCE IV CATHETER SYSTEM | FOZ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| August 20, 1999 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, Inc. | accessdata.fda.gov |
| July 14, 1995 | K952516 | PRO-VENT, LINE DRAW, PULSATOR | JKA | Substantially Equivalent | Smiths Industries Medical Systems, Inc. | accessdata.fda.gov |
| December 29, 1992 | K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| January 30, 1992 | K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| October 23, 1991 | K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| August 9, 1991 | K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| July 17, 1991 | K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| June 21, 1991 | K911638 | SYRINGE TIP CAP | JKA | Substantially Equivalent | Concord/Portex | accessdata.fda.gov |
| September 21, 1981 | K812163 | AIRE-CUF TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bioana Surgical Instruments, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube Tracheostomy And Tube Cuff
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
Updated August 26, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.